“The FDA should be fostering
the transition to safer medications,
not undermining it.”
--Michael Barnes, executive director
of Center for Lawful Access and Abuse Deterrence (CLAAD)
Since the makers of certain extended-release opioids have risen to the call for safer formulations, shouldn't the FDA expect makers of generics to abide by the same rules of safety?
We all know products with tamper-resistant features make extended-release medication far more difficult for people to abuse and convert to an immediate, full dose of the drug. Those concerned about the epidemic of presription drug abuse fought hard for these changes in formula, especially in drugs deemed to cause the most death and destruction.
Preliminary reports show that tamper-resistant opioids are less likely to be abused. For example, in August, 2010, a new formulation of the popular prescription opioid, OxyContin, was introduced, making it more difficult to dissolve or crush, thus discouraging abuse through injection and inhalation. The results were promising: the selection of OxyContin as a primary drug of abuse decreased from 35.6 per cent to 12.8 per cent. Another widely abused pain medication, Opana, was also released in a non-crushable format in early 2012, resulting in an impressive 59 per cent drop in the rate of its abuse.
But, just as it appears that industry has made some progress, albeit small, toward safer opioid formulations, patents are ending on drugs with tamper-resistant formulas—specifically Purdue's OxyContin and Endo's Opana. If the FDA and Congress fail to act, generic versions of extended-release drugs in their original formulations—without a tamper-resistance formula—are due to hit the market in early 2013.
Common sense dictates that if easily abusable formulations are made available again, users seeking a high will turn to them. The generic versions of OxyContin and Opana are expected to be significantly cheaper than the tamper-resistant versions of those drugs. So, what incentives will spur opioid makers to continue to formulate safer products?
Congress can enforce the Stop Tampering of Prescription Pills Act that prevents generics from being approved that are copies of older, more abuse-prone formulations. Dr. Lynn Webster explains:
"In effect, the Stopp Act would sidestep a Catch-22 that now confounds makers of tamper-resistant, extended-release opioids. When the companies developed the new versions, the manufacturers could not legally claim that the new formulas were tamper-resistant—because they had not yet met rigorous and time-consuming FDA testing requirements to prove that claim. Instead the makers of extended-release oxymorphone and oxycodone products simply replaced earlier versions of the medications with the new tamper-resistant ones.
(Lynn Webster MD, "Making Opioid Drugs Less Alluring: Congress Should Act to Continue the Manufacture of Tamper-Resistant Pills," Wall Street Journal, January 13 2013)
According to Webster, the FDA's rule that reformulated products cannot carry labeling claims of tamper resistance until they have been on the market long enough to be sufficiently studied -- plus a lack of clarity on what scientific standards tamper-resistant products must meet --is what allows generics to argue that their products are equivalent.
Consider the possible harmful result when insurance companies and government payers inevitably place generics on a less-expensive tier than brand-name products, ensuring that patients and doctors are forced via pricing to use less-safe medications. The Stopp Act was designed to avoid these sorts of dilemmas, while helping prescribers differentiate the potential safety of the varying formulations.
Over the last year, Purdue Pharma and Endo have backed legislation in Congress that would require many opioids to be tamper-resistant, and lobbied in favor of similar state laws.
They have also urged the Food and Drug Administration to give their tamper-resistant designs a stamp of safety approval that other manufacturers would have to match. Yet, the agency does not currently differentiate between drugs that have abuse-resistant qualities and those that do not.
Of course, some people make a good argument that these pharmaceutical companies wish only to safeguard their profits in blocking generics from issuing earlier, non-tamper-resistant formulations. Yet, in this case, what alternative exists? Here is the answer: "Allow recreational abuse and addictive behaviors to shift to the "old school" opioids with no attendant responsibility placed on the generic manufacturers." Disaster!
Taking Backward "Generic" Steps Has Already Begun
In January 2013, the FDA allowed generic companies to bring the old, crushable form of Opana back to the market despite the fact that the manufacturer of the brand-name version had removed the prior formulation of the drug from the market for safety reasons.
Overdose deaths on opioid pain relievers surpassed deaths from heroin and cocaine for the first time in 2008.
(Donna Leinwand Leger, Opana Abuse in USA Overtakes OxyContin,
USA TODAY, July 11 2012)
(Click to Enlarge)
And now, just a few days ago (February 25, 2013) the Food and Drug Administration (FDA) granted approval for buprenorphine-naloxone tablets to return to the U.S. market in cheaper, generic form. Reckitt Benckiser Healthcare recently removed its non-abuse-deterrent Suboxone tablets from the market after data from the U.S. Poison Control Centers showed an approximate 8-fold increase in accidental pediatric exposure to the tablet product versus an alternative sublingual film.
And, generic drug makers Actavis and Amneal will make the old form of the drug available in early March.
("FDA Undermines Transition to Safer Medications,"
Center for Lawful Access and Abuse Deterrence February 25 2013)
Interestingly, pharmaceutical companies are able to add abuse-deterrent features to these medications without significantly increasing prices for consumers. However, profit is often the primary consideration and crushable pills are in high demand.
According to Eve Pearce of CLAAD, "The need for federal action to keep the old, crushable forms of these powerful pain drugs from devastating more families and communities is urgent.
(Eve Pearce, "Crushable Opana and OxyContin: A Tough Challenge Ahead for Communities
and Families," Center for Lawful Access and Abuse Deterrence, February 21, 2013)
How in the hell can the efforts to end drug abuse stand this setback? Any sensible alternative that detracts from abuse needs to be enforced. To permit crushable forms of these substances to be manufactured again will encourage higher abuse and contribute to greater addiction. Any new generic must be made tamper-resistant.
The FDA needs to get off its ass, get out of bed with Big Pharma, and rank priorities. Priority Number One = Save Lives By Preventing Overdose.
It's time the government and Big Pharma stop worrying about accumulating money. And one "buck" they need to keep and not "pass" is the duty to act responsibly in the midst of a prescription drug health epidemic that drives millions of vulnerable Americans to the Killing Floor.
Every day, 100 people in the US die from drug overdoses; most of these are from prescription drugs. The problem has reached such proportions that the FDA recently deemed it “an epidemic, a societal crisis”. The most commonly involved culprits are opioid analgesics: pain relievers with a powerful potential for abuse, originally prescribed to treat moderate and severe pain, yet abused to such an extent that rate of unintentional overdose deaths associated with them quadrupled between 1999 and 2008.
The problem hits adults and children alike. Between the years 2004 and 2009, the estimated number of emergency department visits related to non-medical use of prescription pain relievers nearly doubled. There is cause for great concern. Communities and families alike must make every effort to ensure that prescription drugs are only employed by those who really need them, in the exact manner prescribed.
Unless communities put due pressure on the federal government to reverse this decision, they will be forced to face swift, harsh consequences, including an increase in pharmacy (and even home) robberies and unintentional overdoses and deaths. And, through our own inaction, we let "the beat go on."
“After OxyContin came on the market fifteen years ago,
a wave of overdose deaths devastated entire towns
in my region of Appalachian Kentucky
before spreading like wildfire to big cities
and suburban communities across the country. “
By crushing these pain pills, abusers can experience
a euphoric – but oftentimes deadly – high.
But today, the FDA has an opportunity keep
these crushable pills out of our children’s reach.
A number of prescription medicines
already on the market use tamper-resistant technologies
that can cut back on abuse.
No generic pill should come to market without these life-saving features.”
--Congressman Harold “Hal” Rogers (KY-05), Co-chairman of the
Congressional Caucus on Prescription Drug Abuse